Soft Tissue Defect Repair Device

ABSTRACT

An inguinal hernia repair device in the form of an implantable plug that is affixed at one end to the center region of a sheet of implantable material. The plug takes the form of a plurality of hollow members, arranged so as to be in substantially parallel relationship when implanted into a defect. The hollow members are preferably tubular members and are preferably bundled together by various means, such as bonding or wrapping a band or strand about the plurality of hollow members to maintain them in adjacent and contacting relationship during insertion into a defect. The device is provided with a base member for anchorage made of a composite material having a non-bioabsorable component and a bioabsorbable component.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 11/015,147,filed Dec. 17, 2004, which is a continuation-in-part of application Ser.No. 10/465,110, filed Jun. 18, 2003, and now issued as U.S. Pat. No.6,991,637.

FIELD OF THE INVENTION

The present invention relates to the field of soft tissue defect repairdevices, and more particularly to the field of inguinal hernia repairdevices.

BACKGROUND OF THE INVENTION

The repair of inguinal hernias is one of the most commonly performedsurgical procedures. Various prosthetic materials, typically porous toallow for tissue ingrowth, have been provided in a variety ofcombinations, forms and shapes. Surgical mesh, typically ofpolypropylene, has been commonly used, in some instances having beenrolled up into a cylindrical shape and inserted into the defect as aplug. To reduce the tendency to migrate, these plugs are sometimesaffixed at one end to the center of a sheet of material. The sheet isused to overlap the defect and for attachment to the adjacent tissue toreduce the likelihood of migration of the device; see, for example, U.S.Pat. No. 5,116,357 to Eberbach and U.S. Pat. No. 5,147,374 to Fernandez.These sheet-and-plug devices lend themselves to laparoscopic repair asthey may be inserted via a trocar wherein, after insertion, the edges ofthe sheet may be fastened to the tissue adjacent the defect.

Hernia repair plug devices have been refined into a variety of shapes.One such commercially available device is the PerFix® Plug from C.R.Bard, Inc. (Murray Hill N.J.), described in U.S. Pat. No. 5,356,432 toRutkow et al. and in revised form by U.S. Pat. No. 5,716,408 to Eldridgeet al. This device is in the form of a pleated conical fabric meshprovided with additional mesh filler material within the hollow of thecone; a sheet of material is not attached to the plug. These attributesare said to aid in the insertion of the device into a hernia defect (Inthe axial direction with regard to the device) and to better enable thedevice to fill the defect in the radial direction. However, there arereported cases of devices of this type having migrated from the site ofthe defect. Further, the mesh filler material is often not adequate toprovide the necessary axial stiffness and radial compliance to theconical form.

U.S. Pat. No. 6,425,924 to Rousseau teaches two opposing conical meshshapes fitted together on a common axis and separated by one or moretubular components, also on the common axis, with the apices of the twocones pointed away from each other. The apex of one cone is affixed tothe center of a sheet of mesh material.

Various materials have been discussed for use as prosthetic plugs forthe repair of inguinal hernias. Polypropylene andpolytetrafluoroethylene are commonly discussed. Polypropylene is mostoften used in the form of a woven or knitted mesh fabric to create thedesired shapes. Polytetrafluoroethylene is typically used in its porous,expanded form, usually noted as ePTFE. Other described non-absorbablematerials include cotton, linen, silk, polyamide (e.g., nylon 66) andpolyethylene terephthalate. Various absorbable materials have also beenproposed, including homopolymers and copolymers of glycolide andlactide, caprolactones and trimethylene carbonates. See, for example,U.S. Pat. No. 6,113,641 to Leroy et al., U.S. Pat. No. 6,180,848 toFlament et al., and U.S. Pat. No. 6,241,768 to Agarwhal et al.

U.S. Provisional Patent Application Ser. No. 60/405,517 to Gingrasdiscloses a soft tissue implant used to treat body defects or to remodeltissue. The implant is in the form of a braided or woven material havinga variety of shapes. The braided or woven material can be made ofnon-absorbable or absorbable polymeric material. The Gingras device doesnot combine absorbable materials with non-absorbable materials, however.An onlay or anchor can be attached to the implant to reduce or eliminatemigration of the implant.

An implantable space-filling tissue repair device having an anchoringelement made of non-bioabsorbable components in combination withbioabsorbable components would provide different tissue responses to theanchoring element at different times during the healing and/orremodeling process. In addition, the bioabsorbable materials of theanchoring element would alter the mechanical characteristics of thenon-bioabsorbable materials of the element. This would allow for morevariability in the design and construction of the non-bioabsorbablematerials of the anchoring element. Once the bioabsorbable material hasdisappeared from the anchoring element, the non-bioabsorbable componentwould remain in place and continue to provide support to the repaired orremodeled tissue.

Accordingly, there remains a need for an implantable medical devicehaving a bioabsorbable and/or non-bioabsorbable space-filling portionand one or more anchoring elements made of non-bioabsorbable materialsin combination with bioabsorbable materials. A preferred bioabsorbablematerial would be a synthetic polymeric material in the form of aself-cohering web.

SUMMARY OF THE INVENTION

The present invention is directed to an inguinal hernia repair device inthe form of an implantable plug that is affixed at one end to the centerregion of a sheet of implantable material, with the length of the plugcomponent oriented to be substantially perpendicular to the sheet. Theimplantable sheet material is substantially planar and serves as a basemember for the implantable plug portion of the present invention toparticipate in anchoring the invention at an implantation site.Accordingly, the implantable sheet material is referred to herein eitheras an “anchoring element,” or a “base member.”

In this invention, the base member is made of one or morenon-bioabsorbable components in combination with one or morebioabsorbable components. The non-bioabsorbable component is preferablypolymeric. Suitable non-bioabsorbable polymeric materials includebiocompatible alkenes, such as polyethylene and polypropylene, andbiocompatible fluoropolymers. Preferred non-bioabsorbable polymericmaterials are configured with a multiplicity of pores, voids, holes, orother spaces through and/or throughout the material. The spaces can beof various sizes and are either isolated or interconnected in thepolymeric material. In preferred embodiments, these spaces in thenon-bioabsorbable component serve as repositories for the bioabsorbablecomponent. In many preferred embodiments, the bioabsorbable component isselectively placed within spaces and/or on surfaces of thenon-bioabsorbable component. Selectively placing the bioabsorbablecomponent on the non-bioabsorbable component permits the tissue responseand the mechanical properties of the base member to be altered, oradjusted, for a particular medical procedure or physiologicalrequirement.

The plug portion of the present invention takes the form of a pluralityof hollow, or substantially hollow, members, arranged so as to be insubstantially parallel relationship when implanted into a defect. Thehollow members are preferably bundled together by various means, such asbonding or wrapping a band or strand about the plurality of hollowmembers to maintain them in adjacent and contacting relationship duringinsertion into a defect.

The hollow members are preferably tubular in shape and can be made ofnon-bioabsorbable materials and/or bioabsorbable materials. Preferably,the hollow members are made of a non-woven bioabsorbable material. Morepreferably, the non-woven bioabsorbable material is in the form of aweb. Most preferably, the non-woven bioabsorbable web is a self-coheringweb. The use of a plurality of hollow members provides for good axialstiffness, beneficial during insertion into the defect, in combinationwith good radial compliance due to the transverse compressibility of therelatively thin-walled tubes. Preferably, a plurality of discrete,individual hollow members are used, with at least one end of each hollowmember remaining open to allow rapid access for body fluids and livingcells. The open end of the hollow members is located at the end of theplug opposite the end that is affixed to the sheet of implantablematerial. As noted above, the plurality of hollow members may be affixedat one end to the center region of a sheet of implantable material thatserves to anchor the device in the preperitoneal space and ensure properplacement and retention of the plug.

In a preferred embodiment, the hollow members are about twice thedesired length of the plug component. Each hollow member is folded inhalf at the midpoint of its length, with all hollow members attached atthe fold to the sheet component. The plurality of folded hollow membersis then bundled together as described above.

The hollow members and the sheet component may be made from any suitableimplantable materials including both bioabsorbable and non-bioabsorbablematerials. The entire device may be made to be non-bioabsorbable, oralternatively the entire device may be made to be absorbable. The plugmay be made to be absorbable and affixed to a non-bioabsorbable sheet,or vice versa. Bioabsorbable materials are preferred, particularly forthe plug component, in that they are anticipated to elicit aninflammatory tissue response that may result in more rapid healing. Themost preferred sheet materials have one or more non-bioabsorbablecomponents placed within, or between, bioabsorbable components.

If desired, the length of the substantially hollow members may bereduced by trimming with a cutting tool.

A preferred bioabsorbable material for the hollow member components andthe bioabsorbable components of the base member material is a copolymerof poly(glycolide:trimethylene carbonate). The copolymer's polyglycolidecomponent is commonly abbreviated as PGA for poly(glycolic acid), thechemical byproduct to which it degrades after hydrolysis. Thepoly(trimethylene carbonate) component is commonly abbreviated as TMC,with the copolymer itself typically referred to as PGA:TMC accompaniedwith relative percentage composition by weight. The preferred PGA:TMCcopolymer embodiment is in the form of a non-woven self-cohering web astaught by Hayes in U.S. Pat. Nos. 6,165,217 and 6,309,423, both of whichare incorporated herein by reference.

Preferably, the non-bioabsorbable component is made of a fluoropolymer.More preferably, the fluoropolymer is polytetrafluoroethylene. Mostpreferably, the polytetrafluoroethylene is porous, expanded,polytetrafluoroethylene (ePTFE). Other polymeric materials suitable foruse in making non-bioabsorbable portions of the device include, but arenot limited to, polyethylene and polypropylene Either or both of thesheet component and the space-filling plug component may optionally betreated (e.g., impregnated or coated) with any of various bioactiveagents, including but not limited to antimicrobials, antibiotics,palliatives, and pharmacological, biochemical, and genetic therapeutics.This is possible regardless of whether the material used for the treatedcomponent is bioabsorbable or non-bioabsorbable.

Accordingly, one embodiment of the present invention is an implantablehernia repair device comprising a plurality of substantially hollowmembers, wherein each substantially hollow member has two ends and atleast one of said ends is open, wherein each substantially hollow memberis made of a bioabsorbable polymeric material in the form of aself-cohering web, and wherein said plurality of substantially hollowmembers is attached to a substantially planar base member in the form ofa composite made of a non-bioabsorbable polymeric material placed withina bioabsorbable polymeric material in the form of a self-cohering web.

Another embodiment of the present invention is an implantable herniarepair device comprising a plurality of substantially hollow members,wherein each substantially hollow member has two ends and at least oneof said ends is open, wherein each substantially hollow member is madeof a bioabsorbable polymeric material in the form of a self-coheringweb, and wherein said plurality of substantially hollow members isattached to a substantially planar base member in the form of acomposite made of a non-bioabsorbable polymeric material placed betweenat least two layers of a bioabsorbable polymeric material in the form ofa self-cohering web.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a hernia repair device of the presentinvention.

FIG. 1A is a side view of a method of making the device of FIG. 1.

FIGS. 1B and 1C are top views further illustrating the method of FIG.1A.

FIG. 2 is a perspective view of an alternative hernia repair device ofthe present invention wherein a corrugated sheet is rolled to create theplug component.

FIGS. 2A and 2B are upper and lower perspective views of the corrugatedsheet prior to rolling up to create the plug.

FIG. 3 is an end view of an embodiment wherein the hollow members havehexagonal transverse cross sections.

FIG. 4 is a perspective view of a hernia plug incorporating a barbcomponent around the circumference of the plug.

FIG. 5 is a perspective view of an embodiment of the hernia repairdevice incorporating a layered sheet component

FIG. 5A shows a cross-section of a composite sheet material for use withthe hernia repair device.

FIG. 5B shows a cross-section of a composite sheet material for use withthe hernia repair device.

FIG. 5C shows a cross-section of a composite sheet material for use withthe hernia repair device.

FIG. 6 is a longitudinal cross section that describes an alternative wayto accomplish the attachment of the plurality of hollow members to thesheet component.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a perspective view of a hernia repair device 10 of the presentinvention, wherein a plurality of hollow, or substantially hollow,members 12 are provided in substantially parallel relationship, creatingplug 14. Preferably, hollow members 12 are tubular as shown in thisembodiment. Optionally and preferably, one end of plug 14 is affixed tothe approximate center of a sheet 16 of composite implantable material.Sheet 16 may optionally be provided with one or more slits 17 as desiredto increase flexibility of sheet 16 and to better enable it to be foldedas necessary for insertion.

Though preferred, hollow members 12 are not required to be tubular.Consequently, each hollow member 12 is not required to have either around or continuous (uninterrupted) circumference. The hollow membersmay, for example, be tubes provided with a slit along all or a portionof their length in order to further increase their radial or transversecompressibility. While round transverse cross sections are preferred,other shapes such as square, rectangular, hexagonal, elliptical, etc.may be used. The transverse cross sectional shapes of the hollow membersmaking up an individual plug may all be the same, or two or moredifferent transverse cross sectional shapes may be used in combinationto make up a single plug.

Hollow members 12 are preferably provided in a bundle that results intheir being substantially parallel to each other when inserted. By“substantially parallel” in this context is meant that the hollowmembers vary only about +/−20 degrees, and more preferably only about+/−10 degrees, from perfectly parallel. The hollow members may bemaintained in a bundled relationship by various bundling means, such asbonding together outer surfaces of adjacent hollow members or wrapping aband 18 or strand about the plurality of hollow members 12 to maintainthem in adjacent and contacting relationship during insertion into adefect. The bundled relationship may also result from the means used toaffix the individual hollow members 12 to a sheet 16.

For embodiments wherein plug 14 is fabricated from a bioabsorbablematerial, band 18 or any other suitable bundling means may be made froman a material that bioabsorbs, bioresorbs, or dissolves faster than thematerial of plug 14. As such, band 18 (or other bundling means) can beexpected to bioabsorb, bioresorb, or dissolve before the plug and willrelease the hollow members to allow them to better conform to the shapeof the defect into which they were inserted when contained by thebundling means.

Hollow, or substantially hollow, members 12 have opposing ends whereinone end of each of the plurality of hollow members remains open, therebyallowing access of body fluids and cells into the luminal space of eachhollow member. This is anticipated to increase the rate of tissueattachment and healing, particularly if the hollow members 12 comprise abioabsorbable material. The end of each hollow member 12 opposing theopen end may be affixed to the central region of sheet 16.

Alternatively, as shown by FIG. 1A, each hollow member 12 may be of alength that is about twice the length of plug 14, wherein individualhollow members 12 are folded in half transversely (indicated by arrows22) at about the midpoint of their length, and attached at the fold tosheet 16.

Attachment of hollow members 12 to sheet 16 may be accomplished in avariety of manners, depending on the configuration of hollow members 12and the materials selected for the hollow members 12 and sheet 16. Thevarious affixing means include the use of adhesives suitable for thechosen materials, various mechanical attachment means such as sewingwith suitable materials (e.g., suture materials), or welding means suchas the appropriate application of heat, solvent welding and/or byultrasonic welding.

A preferred method of making the embodiment with folded hollow membersis shown in the top views of FIGS. 1B and 1C. FIG. 1B shows how a hollowmember 12 may be provided with opposing notches 24 along its sides tobetter enable additional hollow members to be stacked at the sameattachment point as further shown in FIG. 1C. Notches 24 reduce theinterference resulting from multiple hollow members 12 being attached atdifferent angles at the common location. It is apparent that a pluralityof hollow members 12 may be attached at the common location in thismanner. The hollow members may be further provided with a hole 26 at thecenter of the transverse fold line to accommodate a temporary locatingpin (not shown for clarity; for use only during fabrication until theassembly is complete). Conversely, such a locating pin might be madefrom a suitable bioabsorbable material and remain in place as a part ofthe device construction.

FIG. 2 is a perspective view of an alternative hernia repair plug of thepresent invention describing an embodiment wherein the hollow members 12are in the form of a corrugated material 32 that is rolled up orotherwise bundled to form plug 14. The corrugated material 32 may berolled up to create the plug 14 or simply folded and bundled by wrappingwith a band 18 or my other means described previously. Plug 14 isaffixed to sheet 16 as described previously. For any of the embodimentsdescribed herein, the resulting juncture of plug 14 and sheet 16 may beoptionally reinforced by a fillet component 39. Fillet 39 is simply adisc of suitable material fitted around the base of plug 14 with enoughinterference to cause it to fit tightly around the base of plug 14.Fillet 39 may be joined to sheet 16 and plug 14 by various affixingmethods described previously. Alternatively, sheet 16, fillet 39 andband 18 may be formed of a single piece.

FIGS. 2A and 2B show respectively upper and lower perspective views of acorrugated sheet material suitable for rolling or otherwise bundling tocreate plug 14. The corrugated sheet 32 comprises an upper layer 34 thatis corrugated and affixed to a planar lower layer 36 by any suitablemeans. The corrugations result in a plurality of hollow members 12.Rolling of the corrugated sheet 32 to create plug component 14 isaccomplished by rolling in a direction transverse to the length of thecorrugations. As shown by FIG. 2, this results in the corrugations thatprovide the plurality of hollow members 12 extending along the length ofthe cylindrical plug 14, parallel to the longitudinal center line of theplug 14. The ends of the corrugations, opposite the end of the plug thatis subsequently affixed to sheet 16, remain open. The corrugated sheetmaterial 32 may be made from any desired bioabsorbable ornon-bioabsorbable material. These corrugated sheets are anticipated tohave other implantable applications in addition to use as the plugcomponent of the hernia repair device described herein. For example, thecorrugated sheet material 32 may be useful in planar form for the repairof various tissue defects where a somewhat flexible, but “reinforced”sheet is desired. They may also have utility when rolled up to create acylindrical shape appropriate for other applications. The hollow membersresulting from the corrugated construction may be beneficial for variousimplantable applications.

Optionally, as shown by FIGS. 2A and 2B, corrugated sheet material 32may be provided with one or more transverse corrugations 38 on the lowersurface of planar lower layer 36. When the corrugated sheet material isrolled up to create plug 14 of FIG. 2, these corrugations 38 becomebarbs or anchoring features extending circumferentially around the outersurface of plug 14, as will be further described. Corrugations 38 mustbe adequately flexible or distortable to allow the corrugated sheet 32to be rolled up in the direction of their length. If desired,corrugations 38 may be cut transversely at intervals along their lengthto better enable the corrugated sheet 32 to be rolled up FIG. 3 shows atop view of plug 14 wherein the hollow members 12 have hexagonaltransverse cross sections. Plug 14 may result from bundling a pluralityof individual hollow members 12 or alternatively the members may beprovided by extrusion of a honeycomb form wherein adjacent hollowmembers 12 share common walls. It is apparent that hollow members 12 maybe provided in a variety of cross sectional shapes.

FIG. 4 shows a perspective view of a plug 14 provided with a band 18that includes one or more barbs 42, intended to aid in the securement oranchoring of plug 14 within a tissue defect. Additionally, barbs 42 mayserve as the band component 18 that holds hollow members 12 together ina bundle. These barb components 42 may be made in a variety of ways.FIG. 4 shows two barbs made from discs of bioabsorbable material andprovided with flanges 44 that enable the attachment of barbs 42 to theouter surface of plug 14. These anchoring barbs 42 may also be made byproviding transverse corrugations 38 to corrugated sheet 32 prior torolling corrugated sheet 32 to form plug 14, as described previously andshown in FIGS. 2A and 2B.

The preferred bioabsorbable material for making the present invention isin the form of a web of continuous filaments which are made of at leastone semi-crystalline polymeric component covalently bonded as a linearblock copolymer with or blended with one or more semi-crystalline oramorphous polymeric components. The filaments are intermingled togetherto form a porous web of filaments, the filaments having multiple contactpoints with each other within the web. The filaments are bonded at thecontact points without requisite for added adhesive binders, adjuncts orpost extrusion melt processing. The web may be provided in forms withrelatively high cohesive shear strength. The polymeric components of thefilaments exist, at least temporarily, in a homogenous substantiallyphase miscible uncrystallized state. If preserved in the homogenoussubstantially phase miscible uncrystallized state, the object can thenbe manipulated into a distinct desirable molded shape and thensubsequently set or crystallized to retain the desired form particularlysuitable for a specific use or application. Such a web is referred toherein as a “self-cohering,” “self-bonding,” or “autogenous-bonding”web. Accordingly, a self-cohering web has the ability of a melt formedstructure, or component thereof, to effectively self-generate anattachment to itself without the requirement to undergo a melt, orundergo the requisite addition of supplementary adhesives, binders, oradhesive adjuncts either before or after structure formation.

FIG. 5 shows a perspective view of an alternative embodiment whereinsheet 16 is provided in two or more layers which may optionally beattached (e.g., laminated) together to create a composite sheet material51 wherein the two layers have different properties. In a preferredembodiment, composite sheet material 51 includes a non-bioabsorbablelayer 53 and a bioabsorbable layer 55. In use, bioabsorbable layer 55 isplaced in contact with the tissue adjacent the defect. Thenon-bioabsorbable layer 53 is preferably ePTFE and the bioabsorbablelayer 55 is preferably a PGA:TMC material in the form of a self-coheringweb as taught by the Hayes patents referred to above and incorporatedherein by reference.

FIG. 5A shows a cross section of an alternative composite sheet material51 wherein the non-bioabsorbable layer 53 has opposing surfaces 57 and59 with different characteristics, for example, surface 57 being rougherand/or more open than surface 59. Rougher surface 57 is intended toencourage long term tissue attachment and ingrowth while smoothersurface 59 is intended as a barrier to tissue attachment and ingrowth inorder to prevent or reduce the likelihood of tissue adhesions. If layer53 is a porous material, then smoother surface 59 may be provided with asuitably small pore size while rougher surface 57 may be provided with asuitably larger pore size. If desired, sheet 16 may be the result ofattaching two different layers together (as by bonding with an adhesiveor melt bonding, or by mechanical fastening means such as sewing) toachieve the desired different surface characteristics. Rougher surface57 is preferably provided with a covering or coating of bioabsorbablelayer 55; when this layer 55 is bioabsorbed after a suitable time,rougher surface 57 remains to provide the desired long term tissueattachment. The presence of the bioabsorbable layer 55 is anticipated toenhance healing as a result of the increased inflammatory tissueresponse to the bioabsorbable material. This may be desirable due to thechemically inert character of the PTFE material (which consequently doeslittle to elicit a biological reaction from adjacent tissue whenimplanted by itself.

It is also apparent that the bioabsorbable layer 55 may be provided onone surface of an ePTFE material having similar opposing surfaces, aswell as providing such a bioabsorbable layer on one surface of adifferentially-sided ePTFE material.

A preferred material for the non-bioabsorbable layer 53 is Gore-TexDual-Mesh™ with Corduroy™ surface (Flagstaff Ariz.); this material hasopposing surfaces with different tissue attachment and ingrowthcharacteristics as described above.

FIG. 5B shows a cross-section of a sheet material 16 of the presentinvention in the preferred form of a composite sheet material 52 whereinnon-bioabsorbable material 60 is placed within bioabsorbable materials62 and 63. FIG. 5C shows a cross-section of a sheet material 16 of thepresent invention in the preferred form of a composite sheet material 52wherein non-bioabsorbable material 60 is placed between bioabsorbablematerials 62 and 63. Either of these composite sheet materials can serveas preferred base member components of the present invention.

In both embodiments shown in FIGS. 5B and 5C, non-bioabsorbable material60 is preferably a porous, expanded, polytetrafluoroethylene material(ePTFE). More preferably, the ePTFE material has one or more holestraversing the thickness of the material that are visible to the nakedeye. The holes provide for ingrowth of tissue and additional flexibilityof the composite sheet material. Most preferably, these “macroporous”ePTFE materials have holes arranged in a pattern that imparts additionalflexibility to the composite sheet material while retaining sufficientmechanical strength to support damaged or injured tissue throughout thehealing and rehabilitation process.

FIG. 6 is a longitudinal cross section of a band 18 that has been flaredusing suitable tooling to create the bioabsorbable layer 55 that may beadhered to a non-bioabsorbable layer 53 such as ePTFE. This describes analternative way to accomplish the attachment of the plurality of hollowmembers to the sheet component.

The following examples are provided for illustrative purposes only asexamples of particular embodiments of the described invention. As such,they are not intended to be limiting.

EXAMPLES Example 1

This example describes the construction of a multiple tube hernia repairdevice of the present invention as shown in FIG. 1. A triblock copolymerof 67%/33% PGA:TMC (w/w) was acquired from US Surgical (Norwalk Conn.)and formed into a self-cohering web as generally taught by Hayes in U.S.Pat. No. 6,165,217. Sheets of this copolymer web material were formedinto the 3 component types used in the construction of this device.

A first component used for making this device was a tube formed from theself-cohering web sheets that had an area density of approximately 8-10mg/cm² and a thickness of approximately 0.3 mm. The first step in makinga tube was to cut an approximately 25 mm wide strip of the self-coheringweb material from a piece of “unset” web sheet perpendicular to the beltdirection used in forming the web. This strip of “unset” web materialwas then wrapped lengthwise around an approximately 5 mm diameterstainless steel rod into a “cigarette roll” having an exposed edge atthe surface of the resulting tube extending along the length of thetube. This material then self-cohered (as generally taught by Hayes inU.S. Pat. No. 6,165,217) at the overlapping portion of the “cigaretteroll” to form a 5 mm diameter tube that was approximately 150 mm long.The strip of “unset” web material wrapped around the stainless steel rodwas then placed into a Baxter Scientific Products (McGaw Park Ill.)constant temperature oven, model DK-43, for approximately 30 minutes at75° C. to “set” the web. The stainless steel rod and “set” web materialwere then removed from the oven and allowed to cool. After cooling, thetube formed from the now “set” web material was slipped off of thestainless steel rod. Both ends of the “set” web tube were then trimmedleaving a tube that was approximately 90 mm long. Each tube was thenplaced onto a cutting die to create the notches 24 shown in FIG. 1B. Apiece of 0.05 mm thick Mylar® sheet (DuPont Company, Wilmington Del.)was placed over the tube to protect it from contamination. A lightweightplastic-faced mallet was then used to lightly tap onto the tube throughthe Mylar® sheet to cut out two notches 24 and centering hole 26 withthe cutting die. Multiple tubes were made using these methods.

Another component used in making this device was a disc-shaped planarsheet of approximately 38 mm in diameter. This disc-shaped planar sheetwas made by first taking two 50 mm square sheets of the “unset”self-cohering web material, each with an area density of approximately19 mg/cm² and approximately 1 mm thick. The two sheets were then stackedand placed in a restraining frame fitted about the perimeter of thestacked sheets. The restrained web material was then put into the BaxterScientific Products constant temperature oven for approximately 30minutes at 75° C. to bond the two pieces together to create a thickersheet and to “set” the web. After letting the web material cool to roomtemperature, a disc was cut using an approximately 38 mm diametercircular cutting die punch.

A third component used in making this device was a band formed from anapproximately 19 mm wide strip of copolymer web material. This copolymerweb strip had an area density of approximately 6-8 mg/cm² and athickness of approximately 0.3 mm. This was made by rolling the strip of“unset” self-cohering web material into a tube and then holding theoverlapped ends together to allow for self-cohering. The unset webmaterial was then put into a Baxter Scientific Products constanttemperature oven for approximately 30 minutes at 75° C. The resultingband was approximately 19 mm in diameter.

The device was then assembled by taking the disc first and centering iton a centering pin extending from the center of the surface of anassembly fixture. Then six of the tubes with notches and centering holeswere placed on top of the disc, also centering them on the centeringpin. The tubes were arranged so that they were equally spaced radially.The assembly was then placed onto a Branson model 8400 ultrasonic welder(Branson Sonic Power Co., Danbury Conn.). The ultrasonic welder had aBranson catenoidal horn, model 609-010-020 and an approximately 7.6 mmdiameter tip that had an approximately 3.2 mm hole in the center toaccommodate the centering pin of the assembly fixture. The ultrasonicwelder also had a 1:0.6 booster. The downstop was set at approximately0.4 mm with the downspeed set at number 4. Pressure was set atapproximately 0.08 MPa with the trigger set at number 2; time was set to0.2 seconds and the hold duration set at 1.0 seconds.

The ultrasonic welder was shut and activated 3 times for each device.After ultrasonic welding, the six tubes were securely attached to thedisc-shaped sheet. The tubes were then folded up so that they wereoriented to be substantially perpendicular to the sheet component. Theband component was then placed around the tubes to hold them in abundled configuration wherein the tubes were substantially parallel toeach other along their lengths. Four slits, spaced equally apart, werethen cut into the disc approximately three quarters of the way from theperimeter of the disc to the center to facilitate insertion on thedevice into a hernia defect site.

Example 2

This example describes the construction of a corrugated tube herniarepair device of the present invention as shown in FIG. 4. A triblockcopolymer of 50% PGA:TMC (w/w) was made and formed into a self-coheringweb as generally taught by Hayes in U.S. Pat. No. 6,165,217. Sheets ofthis copolymer web material were formed into some of the components usedin the construction of this device. Other components were made fromexpanded polytetrafluoroethylene (ePTFE) and from a bioabsorbablepolymer adhesive, as described below.

A corrugated sheet was made by first placing a piece of the “unset”PGA:TMC web sheet (approximately 100 mm square, about 0.2 mm thickhaving and having an area density of approximately 4-6 gm/cm²) onto apiece of PeCap® polyester screen, product number 7-1000/45 (SefarAmerica, Monterey Park Calif.) material. This screen material, by virtueof its surface texture, was used to restrain the web material fromdimensional change during the “setting” process. A fixture approximately125 mm square was then placed onto the surface of the web sheet. Thefixture was provided with a set of multiple parallel rods with all oftheir centerlines in the same plane, the rods being of approximately 2.4mm diameter and spaced 5.3 mm center-to-center. These rods acted asmandrels for forming the hollow members of the corrugation.

A second piece of “unset” web material of the same type as the first andof approximately the same dimensions was then placed on top of themultiple parallel rod fixture. Unsecured rods of approximately the samediameter as the rods in the fixture were then placed on top of thesecond piece of “unset” web material, between the parallel rods of theunderlying fixture. These unsecured rods were individually pushed downuntil they were in the same plane as the parallel rods of the underlyingfixture. The result was that the second piece of “unset” web materialnow formed the hollow members of the corrugated sheet as it assumed aconvoluted shape with self-cohering contact points on the bottom pieceof “unset” web material. Another piece of PeCap® polyester screen wasplaced on top of the upper piece of “unset” web material to restrain itfrom dimensional changes during the “setting” process. An aluminum platewas placed on top of the polyester and then a weight was placed on topof the entire assembly.

The assembly was then placed into an oven at 80° C. for 30 minutes to“set” the web material. After “setting” in the oven, the web materialwas allowed to cool and then removed from the fixture of multipleparallel rods.

Another component used in making this device was a sheet component witha fillet and band for accepting a rolled up piece of corrugated webmaterial. The first step in making this sheet component was to provide apiece of “unset” web sheet material approximately 50 mm square. Acircular cutting die was used to cut an approximately 13 mm diameterhole in the center of it. A 19 mm diameter aluminum rod, approximately150 mm long, was then fixtured to stand perpendicularly on a flataluminum plate. The piece of “unset” web material with a hole in itscenter was then pushed over the aluminum rod. Since the hole in the“unset” web was smaller than the diameter of the aluminum rod, andbecause the “unset” web material was deformable, the difference indiameters between the hole in the web material and the aluminum rodproduced a flared hole in the “unset” web. The aluminum rod and webmaterial were then placed into an oven at 80° C. for 30 minutes to “set”the web material. After allowing the web material to cool, it wasremoved from the aluminum rod. The flared hole in the “set” web materialformed a combined fillet and band (as in FIG. 6) for accepting thecorrugated web material. The piece of “set” web material with the flangewas then adhered to a piece of ePTFE material by using a bioabsorbableadhesive. The adhesive was made from a mixture of poly(85%d,I-lactide-co-15% glycolide) (by mole; abbreviated as 85% d,I-PLA:15%PGA) mixed 1:4 by weight in acetone. It is apparent that this devicecould be made without the ePTFE layer.

Barb components (FIG. 4, reference no. 42) were individually formed bytaking a piece of “unset” PGA:TMC web material approximately 65 mmlong×13 mm wide and wrapping this lengthwise around a suitably taperedmandrel chosen to shape the downwardly-angled barb. The strip of “unset”web material was temporarily restrained to the mandrel by using a pieceof PTFE pipe tape. The tapered mandrel and restrained “unset” webmaterial were then put into an oven at approximately 80° C. forapproximately 30 minutes to “set” the web material. After the webmaterial was “set” in the oven, it was removed from the mandrel. Cutoutswere then made to the center region of the now tapered band to createflanges 44. The device was then assembled by taking the corrugated sheetand rolling it into a tube. Some of the bioabsorbable adhesive wasapplied to the circumference of one end of this tube and also to thewalls of the filleted band portion to be attached to the sheetcomponent. The end of the tube with adhesive on it was then inserted ina perpendicular orientation into the filleted band portion of the sheetcomponent. Bioabsorbable adhesive was then applied to the interiors of apair of anchoring barbs, after which they were immediately fitted overthe circumference of the plug component.

Example 3

This example describes a method used to alter the stiffness and rate ofbioabsorption of a bioabsorbable device. A solution was made by mixing65% d,I-PLA:35% PGA available from Birmingham Polymers (Birmingham Ala.)in a 1:10 ratio by weight with acetone. A device as described in Example1 was dipped into this solution which imbibed into the structure of thedevice, and then allowed to air dry. The resulting coated device wasstiffer than prior to imbibing. Alternatively, this solution could besprayed onto devices to achieve similar effects. Other copolymer ratioscan also be used to vary the stiffness and rate of bioabsorption. Also,other ratios of polymer:acetone can be used to vary the final amount ofpolymer imbibed into or sprayed onto the structure of the device.

Example 4

This example describes construction of a preferred embodiment of thepresent invention having a base member in the form of a composite sheetmaterial having a non-bioabsorbable component placed within abioabsorbable component. This composite base member can be used with anyof the embodiments described herein.

The composite sheet material for use as the base member of the presentinvention was made in the form of a laminate of a non-bioabsorbableePTFE material and a bioasborbable PGA:TMC self-cohering web material(67:33 weight percent) as taught by Hayes (Ibid.). The ePTFE materialmade according to U.S. Pat. No. 5,858,505, which is incorporated hereinby reference, was obtained from W.L. Gore & Associates, Inc., Flagstaff,Ariz. under the tradename GORE MYCROMESH® Biomaterial. In addition tohaving a plethora of interconnected microscopic sized pores coursingthroughout the body of the ePTFE material, the material has holestraversing the thickness of the material visible to the naked eye. Thestarting materials for the bioabsorbable PGA:TMC component were obtainedas described above in Example 1.

The composite material was constructed by centering a circular 7 cmdiameter piece of ePTFE material between two 10 cm×10 cm sheets ofPGA:TMC material. The PGA:TMC material was in the form of an unset webhaving an area density between 20 mg/cm² and 25 mg/cm². The compositewas overlaid on both sides with a woven polyester web material (SEFARAMERICA, INC, SEFAR product number 7-1000/45 PeCap® polyester endlessbelt) and placed in a restraining apparatus. Approximately five (5)pounds of force was applied to the polyester web pieces with theapparatus.

The restrained combination was placed in a constant temperature oven at100° C. for ten (10) minutes in order to set the bioabsorbable PGA:TMCweb material and enclose the non-bioabsorbable ePTFE material within thebioabsorbable material. The composite material was allowed to cool toroom temperature before being removed from the restraining apparatus.

Excess bioabsorbable material was trimmed from the composite sheetmaterial to form a base member of the present invention. The base memberwas attached to a plurality of substantially hollow members as describedin Example 1.

Example 5

This example describes construction of a preferred embodiment of thepresent invention having a base member in the form of a composite sheetmaterial having a non-bioabsorbable component placed between layers ofbioabsorbable material. In this example, the bioabsorbable self-coheringweb had a volume percent of 67:33, an area density of approximately 50mg/cm², and a volume density of 0.35 g/cc. The ePTFE material wasobtained from W.L. Gore & Associates, Inc., Flagstaff, Ariz. under thetradename GORE DUALMESH® Biomaterial. The ePTFE material is in the formof a sheet having different textures on opposite sides of the sheetmaterial to elicit different tissue responses at an implantation site.

In this example, the non-bioabsorbable ePTFE material was placed betweentwo layers of bioabsorbable PGA:TMC material, restrained as described inExample 4, and ultrasonically welded together.

The ultrasonic welder had a Branson circular high gain horn, model 318004 145 with an approximately 5 cm diameter tip having a machined facehoneycomb hole pattern. Each 6 mm hexagon machined hole in the honeycombpattern was spaced at 1 mm. The ultrasonic welder also had a 1:2.5booster. The downspeed was set at number 4. Applied pressure was set atapproximately 0.65 MPa with the trigger set at number 2. The weldingtime was 0.8 seconds and assembly held in place for a duration of 2.5seconds.

Excess bioabsorbable material was trimmed from the composite sheetmaterial to form a base member of the present invention. The base memberwas attached to a plurality of substantially hollow members as describedin Example 1.

While the principles of the invention have been made clear in theillustrative embodiments set forth herein, it will be obvious to thoseskilled in the art to make various modifications to the structure,arrangement, proportion, elements, materials and components used in thepractice of the invention. To the extent that these variousmodifications do not depart from the spirit and scope of the appendedclaims, they are intended to be encompassed therein.

1. An implantable device comprising a plurality of substantially hollowmembers; wherein each said substantially hollow member has a length anda midpoint along said length; wherein each substantially hollow memberhas two ends and at least one of said ends is open; and wherein eachsubstantially hollow member is attached to a substantially planar basemember at about said midpoint of said substantially hollow member. 2.The implantable device of claim 1 comprising a bioabsorbable material.3. The implantable device of claim 2 wherein said bioabsorbable materialcomprises polyglycolic acid.
 4. The implantable device of claim 3wherein said bioabsorbable material comprises trimethylene carbonate. 5.The implantable device of claim 1 comprising a non-bioabsorbablematerial.
 6. The implantable device of claim 5 wherein saidnon-bioabsorbable material comprises polytetrafluoroethylene.
 7. Theimplantable device of claim 1 comprising a bioabsorbable material and anon-bioabsorbable material.
 8. The implantable device of claim 7 whereinsaid bioabsorbable material comprises polyglycolic acid
 9. Theimplantable device of claim 8 wherein said bioabsorbable materialcomprises trimethylene carbonate.
 10. The implantable device of claim 7wherein said bioabsorbable material comprises trimethylene carbonate.11. The implantable device of claim 7 wherein said non-bioabsorbablematerial comprises polytetrafluoroethylene.
 12. The implantable deviceof claim 8 wherein said non-bioabsorbable material comprisespolytetrafluoroethylene.
 13. The implantable device of claim 9 whereinsaid non-bioabsorbable material comprises polytetrafluoroethylene. 14.The implantable device of claim 10 wherein said non-bioabsorbablematerial comprises polytetrafluoroethylene.
 15. The implantable deviceof claim 1 wherein said substantially hollow members comprise abioabsorbable material.
 16. The implantable device of claim 15 whereinsaid bioabsorbable material comprises polyglycolic acid
 17. Theimplantable device of claim 16 wherein said bioabsorbable materialcomprises trimethylene carbonate.
 18. The implantable device of claim 15wherein said bioabsorbable material comprises trimethylene carbonate.19. The implantable device of claim 15 wherein said substantially planarbase member comprises a non-bioabsorbable material.
 20. The implantabledevice of claim 19 wherein said non-bioabsorbable material comprisespolytetrafluoroethylene.
 21. The implantable device of claim 16 whereinsaid substantially planar base member comprises a non-bioabsorbablematerial.
 22. The implantable device of claim 21 wherein saidnon-bioabsorbable material comprises polytetrafluoroethylene.
 23. Theimplantable device of claim 17 wherein said substantially planar basemember comprises a non-bioabsorbable material.
 24. The implantabledevice of claim 23 wherein said non-bioabsorbable material comprisespolytetrafluoroethylene.
 25. The implantable device of claim 18 whereinsaid substantially planar base member comprises a non-bioabsorbablematerial.
 26. The implantable device of claim 25 wherein saidnon-bioabsorbable material comprises polytetrafluoroethylene.
 27. Theimplantable device of claim 1 wherein said substantially planar basemember comprises a non-bioabsorbable material.
 28. The implantabledevice of claim 27 wherein said non-bioabsorbable material comprisespolytetrafluoroethylene.
 29. The implantable device of claim 27 whereinsaid substantially planar base member further comprises a bioabsorbablematerial.
 30. The implantable device of claim 28 wherein saidsubstantially planar base member further comprises a bioabsorbablematerial.
 31. The implantable device of claim 28 wherein saidbioabsorbable material comprises polyglycolic acid.
 32. The implantabledevice of claim 29 wherein said bioabsorbable material comprisestrimethylene carbonate.
 33. The implantable device of claim 29 whereinsaid bioabsorbable material comprises polyglycolic acid.
 34. Theimplantable device of claim 1 wherein the implantable device is a herniarepair device.
 35. The implantable device of claim 1 wherein theimplantable device is a soft tissue repair device.
 36. An implantabledevice comprising at least one substantially hollow member; wherein saidat least one substantially hollow member has a length and a midpointalong said length; wherein each substantially hollow member has two endsand at least one of said ends is open; and wherein each substantiallyhollow member is attached to a substantially planar base.
 37. Theimplantable device of claim 36 wherein the substantially hollow memberis attached to the substantially planar base at about said midpoint ofsaid substantially hollow member.
 38. The implantable device of claim 1wherein the substantially hollow member is conformable to the shape of adefect.
 39. The implantable device of claim 1 wherein the plurality ofhollow members are compressible.